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NCT Number: NCT06577857

Inferonasal MIMS® Procedure: Long-Term Follow-Up Extension Study

A long-term (24 and 30 months) follow-up extension, prospective, non-interventional, open label study for data collection from subjects who underwent prior MIMS® inferonasal surgery, in continuation of the previous clinical investigation with the MIMS® Device (MMS-EEU-5).

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Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

S. Malayan Eye Center

Yerevan, Armenia

Location status: Recruiting

Location contact

Lilit A Voskanyan, MD

CONTACT

+374-10-34-49-44

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject who underwent MIMS® inferonasal procedure, and surgery was performed not earlier than 24 months from enrollment

Treatment and study plan

Inferonasal Minimally Invasive Micro Sclerostomy

Device

The Inferonasal MIMS® procedure uses the proprietary MIMS® device, which creates a sclerostomy in the inferonasal quadrant of the eye.

Other names: Inferonasal MIMS

Primary outcomes

  1. Intraocular Pressure Change (Baseline to 24 months)

    Time frame: Baseline to 24 months post-MIMS® surgery

    Change in IOP from medicated baseline to 24 months post-MIMS® surgery

  2. Intraocular Pressure Change (Baseline to 30 months)

    Time frame: Baseline to 30 months post-MIMS® surgery

    Change in IOP from medicated baseline to 30 months post-MIMS® surgery

  3. Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 24 Months)

    Time frame: Medicated baseline to 24 months post-MIMS® surgery

    Change in the number of topical IOP-lowering medications from medicated baseline to 24 months post-MIMS® surgery

  4. Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 30 Months)

    Time frame: Medicated baseline to 30 months post-MIMS® surgery

    Change in the number of topical IOP-lowering medications from medicated baseline to 30 months post-MIMS® surgery

  5. Surgery Success Rate (24 months)

    Time frame: 24 months post-MIMS® surgery

    Success rate 24 months post-MIMS® surgery

  6. Surgery Success Rate (30 months)

    Time frame: 30 months post-MIMS® surgery

    Success rate 30 months post-MIMS® surgery

Secondary outcomes

  1. Postoperative Complication Safety Outcomes

    Time frame: Baseline to 30 months post-MIMS® surgery

    Late (greater than 12 months) postoperative complications

  2. Interventional Safety Outcomes

    Time frame: Baseline to 30 months post-MIMS® surgery

    Late (greater than 12 months) postoperative interventions

Study contacts

Contact information is provided by the study sponsor or research team.

Khan Lau, OD

CONTACT

[email protected]

8082862666

Sponsors and collaborators

Lead sponsor

Sanoculis Ltd

Industry

Registry information

Official study title

Minimally Invasive Micro Sclerostomy (MIMS®) Inferonasal Procedure: Long-Term Follow-Up Extension Study

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2024
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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